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Not yet recruitingNCT07642973DexpanthenolUpdated Jun 16, 2026

A Study to Evaluate the Safety and Clinical Performance of a Dexpanthenol Medicated Hydrogel Patch in the Treatment of Standardized Superficial Abrasions

An interventional study of hydrogel plaster with dexpanthenol and Standard plaster in Skin Wounds and Abrasion, sponsored by Wooshin Labottach Co., Ltd.. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Wooshin Labottach Co., Ltd. · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

Clinical evaluation of a Dexpanthenol-medicated wound plaster on standardized superficial skin abrasions

Read the detailed description

By utilizing a standardized abrasion model (based on the Wigger-Alberti methodology), the study aims to quantify the superior clinical performance of the Plaster compared to a standard plaster (conventional dry) and dry healing (no plaster). This evidence is crucial to demonstrate that the presence of Dexpanthenol provides a significant clinical benefit in terms of healing speed and aesthetic quality of the repaired tissue.

02

Conditions studied

  • Skin Wounds
  • Abrasion

Keywords

  • superficial wounds
  • dexpanthenol
  • plaster
03

In context

Lead sponsor

Wooshin Labottach Co., Ltd. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male or female volunteers aged 18 to 64 years (inclusive).
  • Informed consent form signed voluntarily before any study-related procedure.
  • Subjects willing and able to comply with all study protocol requirements, including scheduled visits and home-wear restrictions.
  • Intact, healthy skin on both volar forearms (free of tattoos, scars, sunburns, or active skin lesions in the designated test areas).
  • Agree to take precautions to prevent pregnancy (applicable only to non-menopausal women), including abstinence, intrauterine devices (IUDs), progestogen implants, combined estrogenic-progestogen contraceptives, the use of condoms;

Exclusion criteria

Exclusion Criteria:

  • Known hypersensitivity or allergy to Dexpanthenol, hydrogel components, acrylic adhesives, or any component of the investigational devices.
  • History of keloid formation, hypertrophic scarring, or abnormal wound healing.
  • Active dermatological conditions (e.g., psoriasis, eczema, atopic dermatitis, active infections) on the upper extremities.
  • History of diabetes mellitus, peripheral vascular disease, or arterial/venous microangiopathy.
  • Systemic treatment with corticosteroids, immunosuppressive drugs, Anticoagulants, antiplatelet agents or cytostatic agents within 4 weeks prior to Baseline, or anticipated need during the study.
  • Topical treatment (steroids, retinoids, antibiotics, or moisturizers) applied to the volar forearms within 2 weeks prior to Baseline.
  • Active heavy smokers (more than 10 cigarettes per day) or users of nicotine-replacement therapies (nicotine alters cutaneous microcirculation and significantly impairs wound healing kinetics)
  • Pregnant or lactating women, or women of childbearing potential not using highly effective contraception (see inclusion criteria).
  • Not willing and able to comply with all study protocol requirements
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Dexpanthenol

    On the wound will be applied an experimental Hydrogel plaster with Dexpanthenol

    Device: hydrogel plaster with dexpanthenol

  • Active comparator
    Standard plaster

    On the wound will be applied a standard plaster, with no active ingredients

    Device: Standard plaster

  • No intervention
    No treatment

    The wound is not covered or medicated

Interventions

  • Devicehydrogel plaster with dexpanthenol

    On the wound will be applied daily an hydrogel plaster with Dexpanthenol

  • DeviceStandard plaster

    On the wound will be daily applicated a standard plaster on the market

06

What researchers measure

Primary outcomes

  1. Re-epithelialization Rate

    Measured as the percentage of wound closure compared to baseline (T0) with standardized photography

    Time frame: day 5 day 7 day 15

Secondary outcomes

  1. Kinetics of Wound Closure

    Time to 50% re-epithelialization

    Time frame: Day 5 day 7

  2. Subject-Reported Pain

    Pain during wear and upon plaster removal assessed via a 100-mm Visual Analogue Scale (VAS)

    Time frame: day 5 day 7

  3. Scar Quality Assessment

    using the Vancouver Scar Scale (VSS) (scoring vascularity, pigmentation, pliability, and height)

    Time frame: day 5 day 7 day 15

  4. general usability

    Assessment of the plaster adherence to the perilesional skin over the treatment period using a 5-Point Adhesion Score 0 (100%) to 4 (0% fallen)

    Time frame: Day 1, day 5, day 7

Other outcomes

  1. Number of AE

    Safety outcome

    Time frame: from day 1 to day 15 (all the study duration)

07

Study locations

1 site
  • la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud
    Monselice, PD 35043, Italy
08

References and documents

Individual participant data

Plan to share: Yes — When study will be closed and published

Supporting information: Study protocol, Sap, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07642973
Lead sponsor
Wooshin Labottach Co., Ltd.
Collaborators
Nextrasearch S.r.l.s.
Responsible party
Sponsor
First posted
Jun 11, 2026
Start date
Sep 2026 (estimated)
Primary completion
Oct 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 16, 2026

Study contacts

Alessandro Guzzo, MD
Contact
alessandro.guzzo@aulss6.veneto.it
+39 0429715610
Adolfo Gasparetto, MD
Contact
adolfogasparetto@nextrasearch.it
+39 3356641965
Alessandro Guzzo, MD
principal investigator · la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud con indirizzo via Albere, 30 Monselice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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